S/P SERUM DROPPER PIPETS— 510(k) K812892

Substantially Equivalent

American Dade

FDA 510(k) clearance K812892 for S/P SERUM DROPPER PIPETS, Substantially Equivalent on 1981-10-27. Applicant: American Dade. Device class: 1.

Clearance details

Applicant: American Dade
Product code: Code KSS
Device class: Class 1
Regulation: 21 CFR 864.9050
Advisory panel: Hematology
Date received: 1981-10-15
Decision date: 1981-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KSS

K874436 — FLUID SAMPLING PACK1988-01-05
K801386 — PRE-DENT SYSTEM OR PRE-DENT II1980-07-14
K801516 — PRE-DENT SYSTEM MODIFIED1980-07-14
K800736 — PRE-DENT SYSTEM1980-04-24
K761303 — IMMU-SAL IMMUNOHEMATOLOGICAL SALINE1976-12-30

More clearances from American Dade

K873051 — STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY1987-10-20
K873171 — STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-29
K873052 — STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY1987-09-14
K872789 — PARAMAX URINE/CSF CALIBRATOR1987-09-02
K872195 — DATA-FI DIMERTEST LATEX ASSAY1987-08-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.